SEARCH · PubMed Health

Results for “Random Allocation”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 1,117 records · Page 62Linked to original sources

PubMed1983

Comparison of vincristine and vindesine in the treatment of inoperable non-small cell bronchial carcinoma.

Sixty-three patients with inoperable symptomatic non-small cell carcinoma of the bronchus were randomly allocated to receive either vincristine (1.4 mg/m2) or vindesine (3 mg/m2). These drugs were given weekly for four doses, then every 2 weeks for two further doses, and then continued monthly if there had been a response. Only five partial responses (greater than 50% reduction) were obtained with vindesine and none with vincristine. Disabling toxic effects occurred in 13 patients. This was more common with vindesine, but this group also received more prolonged therapy. Vindesine has modest activity against non-small cell carcinoma of the bronchus and may be more effective than vincristine, with similar toxicity.

Adult↗

PubMed1988

[Etomidate versus etomidate and hydrocortisone for anesthesia induction in abdominal surgical interventions].

The imidazole derivative etomidate has been shown to block (reversibly) adrenocortical steroid synthesis. Long-term sedation with etomidate has been associated with adrenocortical insufficiency and increased mortality in severely ill patients. The significance of adrenocortical blockade after a single induction dose of etomidate remains a matter of debate. This study was designed to analyze the role of glucocorticoid deficiency after a single induction dose of etomidate for major surgery. In a prospective controlled double-blind study, 20 consecutive patients scheduled for colorectal surgery were randomly allocated to either hydrocortisone substitution or placebo (glucose 5%). Hydrocortisone was given as a continuous infusion in a dose of 100 mg dissolved in 5% glucose over 10 h. We combined general anesthesia and epidural anesthesia (L3-4) using bupivacaine (0.5%). Induction of anesthesia: etomidate (0.2-0.3 mg/kg), fentanyl (0.1-0.2 mg), pancuronium (2 mg), and succinyl-choline (1.0-1.5 mg/kg), with endotracheal intubation and mechanical ventilation. Anesthesia was maintained at N2O/O2 2:1 and fluothane (0.4-0.6 vol%). At the end of surgery patients were extubated after oxygenation. In all patients blood pressure, heart rate, central venous pressure, and ECG were monitored continuously, both intra- and postoperatively. During induction, patients received 1,000 ml 0.9% NaCl, followed by continuous administration of 0.9% NaCl, 6 ml/kg per hour intraoperatively and 40 ml/kg per 24 hours post-operatively.(ABSTRACT TRUNCATED AT 250 WORDS)

Adrenal Insufficiency↗

PubMed1985

[Hormone receptors and endocrine therapy of renal carcinoma].

One hundred sixty-five consecutive patients with resectable renal cancer entered a cooperative study to evaluate hormone treatment and steroid receptors. Twenty-nine patients with concomitant distant metastases (category M1) received intramuscular medroxyprogesterone acetate (MPA) 500 mg/day for at least two months after the operation. No measurable remission was observed, but 8 of 24 evaluable patients (33%) had disease stabilization for a median duration of 6 months. One hundred thirty-six cases with category M0 cancer were randomly allocated to a control group or to a treatment group with MPA 500 mg/3 times a week for one year. After a median follow-up period of over 3 years, 30 of 121 evaluable patients (24.8%) had a relapse, usually in distant sites. Relapses and survival were independent from postoperative treatment and sex. Only the extent of the disease and the presence of steroid receptors in the tumor were related with prognosis, but no relation could be found between receptors and response to hormone treatment. The presence of low concentrations of hormone receptors in a proportion of renal cancers remains unclear. However, MPA is confirmed to be only marginally active in metastatic renal cancer and the drug cannot be recommended as adjuvant to radically resected patients because of significant toxicity and lack of therapeutic activity.

Adolescent↗

PubMed1988

[A randomized controlled trial comparing short-term MF chemotherapy with MF plus long-term HCFU chemotherapy as an adjuvant to a curative resection of stomach cancer: Mifurol Study Group for Stomach Cancer].

In order to clarify the clinical response of long-term adjuvant chemotherapy using Carmofur (HCFU), a comparative multicenter trial has been performed by a randomized controlled method. Curative resected patients suffering from stomach cancer were randomly allocated into two arms. Arm A consisted of short-term MF chemotherapy (mitomycin C 0.04 mg/kg plus 5-fluorouracil 5.0 mg/kg x 6 bolus i.v.) and arm B consisted of arm A plus long-term HCFU chemotherapy (HCFU 6-12 mg/kg/day over 12 weeks, p.o.). The difference of overall survival probability between the two studied arms significantly supported arm B therapy (generalized Wilcoxon test: p = 0.0405) up to 5 years after surgery. The difference of the survival curves was clearer in the case of patients with cancers in the advanced stage, such as a positive serosal inversion and a lymph node metastases [ps(+).n(+)]. The side effects of HCFU, most patients experiencing subjective symptoms such as gastrointestinal toxicities, polyuria, and hot sensation, were reversible. Our results suggest that HCFU maintenance therapy has effect on preventing the postsurgical recurrences of stomach cancer and elongating the patient's survival.

Antineoplastic Agents↗

PubMed1985

Comparison of pirenzepine and carbenoxolone in the treatment of chronic gastric ulcer. A double-blind endoscopic trial.

The purpose of the present study was to compare the effectiveness of pirenzepine and carbenoxolone in accelerating the healing of chronic gastric ulcer. Sixty-six out-patients with endoscopically proven gastric ulcer, without major systemic diseases, were admitted to the study. Patients were randomly allocated to either pirenzepine, 50 mg three times a day for 6 weeks, or carbenoxolone, 100 mg three times a day for one week followed by 50 mg three times a day for the remaining five weeks. At 6 weeks, the ulcers had healed in 20 out of 34 patients (59%) treated with pirenzepine, and in 15 out of 29 patients (52%) treated with carbenoxolone. Symptomatic improvement was similar with both drugs. Some major side effects (oedema, hypokalaemia and hypertension) occurred in approximately 30% of patients treated with carbenoxolone; of those receiving pirenzepine 25% complained of minor symptoms (e.g. dry mouth, headache, tachycardia). It is concluded that pirenzepine and carbenoxolone are of similar, but rather limited, efficacy in speeding the healing of chronic gastric ulcer, but show important differences with respect to tolerability.

Anti-Ulcer Agents↗

PubMed1982

The effect of prostatectomy on upper urinary tract function.

59 patients with obstructive prostatic hypertrophy (BPH) were evaluated regarding the influence of prostatectomy on upper urinary tract function by means of [51Cr]EDTA clearance and gamma camera renography measurements. 25 patients were randomly allocated to transvesical and 34 patients to transurethral prostatectomy. At the 6-month follow-up a slight decrease in glomerular filtration rate (GFR) was seen in the total patient group. Residual renal activity 20 min following injection (A20) as well as half-peak time values showed upper urinary tract obstruction in 54% of the patients preoperatively, whereas dilatation of the upper urinary tract was demonstrated at i.v. pyelography in only 15%. Patients with renographic obstruction preoperatively had low GFR values compared with patients without obstruction. In patients with upper urinary tract obstruction, prostatectomy relieved the obstruction, even in the case of normal urography. In patients with normal upper urinary tract, a clinically insignificant decrease in GFR and increase in A20 and half-peak time was observed. No differences with regard to upper urinary tract function were seen on comparing transurethral with transvesical prostatectomy.

Aged↗

PubMed1988

Failure of single-dose metronidazole prophylaxis in colorectal surgery. No benefit from high dosage or combination with nalidixic acid.

In an open prospective study of postoperative infectious complications, patients undergoing elective colorectal surgery were randomly allocated to one of three groups receiving parenteral single-dose antimicrobial prophylaxis (1 g or 3 g metronidazole or 1 g metronidazole + 3 g nalidixic acid). Because of an unacceptably high rate of surgical infection in all three groups (36%, 29% and 39%, p greater than 0.1) among the first 103 evaluable patients, the study was discontinued. Nalidixic acid--though effective in in vitro tests of bacterial susceptibility--thus was found to be of little or no value as prophylaxis against Gram-negative infection. As the observed infection rate when metronidazole was given at the start of operation was seven-fold that previously found in the same department when 1 g metronidazole was administered 3-4 hours preoperatively (28/103 vs. 2/50, p less than 0.01), the timing of metronidazole prophylaxis was assumed to be potentially important for its ability to protect also against aerobic postoperative infection.

Adult↗

PubMed1981

Adverse reactions to bendrofluazide and propranolol for the treatment of mild hypertension. Report of Medical Research Council Working Party on Mild to Moderate Hypertension.

Participants in the Medical Research Council treatment trial for mild hypertension are randomly allocated to one of four treatment groups: bendrofluazide, propranolol, or a placebo for either of these drugs. The trial is single-blind. 23 582 patient-years of observation have been completed so far, 10 684 on active drugs and 12 898 on placebos. The results show an association between bendrofluazide treatment and impotence, and impotence also occurred more frequently in patients taking propranolol than in those taking placebos. Other adverse reactions significantly linked with active drugs include impaired glucose tolerance in men and women and gout in men, associated with bendrofluazide treatment, and Raynaud's phenomenon and dyspnoea in men and women taking propranolol. No corneal disease is known to have occurred in the propranolol group. Mean serum potassium level fell, and urea and uric acid levels rose, in men and women taking bendrofluazide. In the propranolol group, serum potassium and uric acid levels rose in both sexes, but the urea level rose significantly in women only.

Adult↗

PubMed1982

A randomised controlled trial of the effects of screening for ulcer-type dyspepsia.

One hundred and ninety-nine male London office workers with dyspeptic symptoms elicited by a self-administered questionnaire were randomly allocated to intervention and control groups to assess the potential benefits of screening. The members of the intervention group were interviewed and examined, and those men who were considered to have a possible or probable peptic ulcer received a barium meal examination (53%). At the clinical interview the intervention group were advised against both smoking and drinking alcohol. Eighteen months later both groups were recalled for interview and examination and their sickness absence in the intervening period was assessed. The intervention group did not alter their cigarette consumption but did reduce their alcohol intake by an average of 10%. The control group increased their alcohol intake by 20%. Both groups tended to improve symptomatically, and there were no differences in symptoms between the groups at the end of the study. Sickness absence was not affected by the intervention. It is concluded that screening for ulcer-type dyspepsia is not justifiable in male London office workers.

Adult↗

PubMedDate not supplied

A prospective randomized study of two sclerotherapy techniques for esophageal varices.

In a study designed to compare the efficacy and safety of two techniques of injection sclerotherapy, 40 patients (30 with cirrhosis and 10 with portal vein block) were randomly allocated to the sheath or free-hand technique. Although the former was associated with significantly less bleeding within the first 24 hr of injection (p less than 0.05) but more postinjection pain (p less than 0.05) and esophageal stricture, there was a trend toward earlier obliteration of varices. This was most marked over the first three courses of injection, and although frequency of rebleeding was not significantly less, none of the 11 episodes in the sheath group were fatal, compared to 5 of 15 bleeds in those injected by the free-hand technique (p less than 0.05).

Clinical Trials as Topic↗

PubMed1986

[A randomized controlled trial comparing short-term MF chemotherapy with MF and long-term carmofur chemotherapy as an adjuvant to curative resection of stomach cancer].

In order to clarify the clinical response to long-term adjuvant chemotherapy with carmofur (HCFU), a comparative multicenter trial has been performed by a randomized controlled method. Curatively resected patients suffering from stomach cancer were randomly allocated into two arms. Arm A consisted of those receiving short-term MF chemotherapy (mitomycin C, 0.04 mg/kg + 5-fluorouracil, 5.0 mg/kg X 6, IVr) and arm B consisted of arm A plus long-term carmofur chemotherapy (Mifurol, 6-12 mg/kg/day over 12 weeks, PO). The difference of overall survival probability between the two study arms was significant in fabior of arm B (P less than 0.05) up to three years after surgery. The difference of survival curves was more distinct (P less than 0.01) in the case of the advanced stage of the cancer such as serosal inversion [ps (+)] and lymph node metastasis [n (+)]. The side effects of carmofur, mostly subjective symptoms such as gastrointestinal toxicities, pollakisuria, and sensation of hotness, were reversible. From the results, it is suggested that carmofur maintenance therapy is effective for the prevention of postsurgical recurrence of stomach cancer by means of the prolongation of patient survival.

Antineoplastic Agents↗

PubMed2004

Falls prevention in residential care homes: a randomised controlled trial.

OBJECTIVE: to determine the effect of risk factor modification and balance exercise on falls rates in residential care homes. DESIGN: cluster randomised controlled trial. PARTICIPANTS: 196 residents (aged 60 years or over) in 20 residential care homes were enrolled (38% response rate). Homes were randomly allocated to intervention and control arms. A total of 102 residents were consigned to the intervention arm and 94 to the control arm. INTERVENTION: a multifactorial falls prevention programme including 3 months gait and balance training, medication review, podiatry and optometry. MAIN OUTCOME MEASURES: number of falls/recurrent falls per person, number of medications per person, and change in Tinetti gait and balance measure. RESULTS: in the intervention group there was a mean of 2.2 falls per resident per year compared with 4.0 in the control group; this failed to reach statistical significance (P = 0.2) once the intra-cluster correlation (ICC, 0.10) had been accounted for. Several risk factors were reduced in the intervention arm. CONCLUSIONS: falls risk factor reduction is possible in residents of care homes. A modest reduction in falls rates was demonstrated but this failed to reach statistical significance.

Accidental Falls↗

PubMed1988

Sports injury research. How to choose a study design.

In conducting a clinical study, one must determine the timing of the study. A cohort study may be either retrospective or prospective. A case-control study is retrospective and compares subjects with a particular condition to controls without that condition by evaluating events which preceded the development of the condition. A cross-sectional study examines subjects at one particular moment in time. Once the timing of a study is determined, the type of control group is selected. One may present an uncontrolled series or use historical or concurrent controls. The prospective, concurrently controlled series is the strongest of the above designs. The randomized clinical trial is the strongest study design and is employed to avoid the errors that are potentially present in non-randomized studies (Chapter 9). It is a prospective, concurrently controlled study design in which subjects are randomly allocated to two or more treatment modalities. The protocol specifies the population source, admission criteria, enactment of the procedure, and outcome determination for the study.

Clinical Trials as Topic↗

PubMed1987

Comparison of paracentesis and diuretics in the treatment of cirrhotics with tense ascites. Results of a randomized study.

To investigate whether paracentesis could be an alternative therapy for ascites, 117 cirrhotics with tense ascites were randomly allocated into two groups. Fifty-eight patients (group 1) were treated with paracentesis (4-6 L/day until disappearance of ascites) and intravenous albumin infusion (40 g after each tap). Fifty-nine patients (group 2) were treated with spironolactone (200-400 mg/day) plus furosemide (40-240 mg/day). Patients from group 2 not responding to diuretics were treated with a LeVeen shunt. After disappearance of ascites, patients from both groups were discharged from hospital and were instructed to take diuretics. Patients developing tense ascites during follow-up were readmitted to hospital and treated according to their initial schedule. Paracentesis was effective in eliminating the ascites in 56 patients from group 1 (96.5%) and did not induce significant changes in renal and hepatic function, plasma volume, cardiac index, peripheral resistance, plasma renin activity, plasma norepinephrine and antidiuretic hormone concentration, and urinary excretion of prostaglandin E2 and 6-keto-prostaglandin F1 alpha. Diuretics were effective in eliminating the ascites in 43 patients from group 2 (72.8%) (p less than 0.05). Ten patients in group 1 and 36 in group 2 developed complications during their first hospital stay (p less than 0.001). This difference was due to the significantly higher incidence of hepatic encephalopathy, renal impairment, and electrolyte disturbances occurring in patients treated with diuretics. The duration of hospital stay was 11.7 +/- 1.5 days for patients from group 1 and 31 +/- 2.8 days for patients from group 2 (p less than 0.001). The two groups did not differ significantly with respect to the probability of requiring readmission to hospital during follow-up, reasons for readmission, survival probability after entry into the study, and causes of death. These results indicate that paracentesis associated with intravenous albumin infusion is a fast, effective, and safe therapy for ascites in patients with cirrhosis.

Albumins↗

PubMed1991

Lipid responses of hypercholesterolemic men to oat-bran and wheat-bran intake.

The hypocholesterolemic effects of oat bran (OB) have been recently challenged. To carefully document the hypocholesterolemic effects of OB, 20 hypercholesterolemic men admitted to a metabolic ward were randomly allocated to either OB or wheat bran (WB) for 21 d after a 7-d control-diet period. Control and treatment diets were designed to be identical in energy content and nutrients, differing only in the amount of soluble fiber. After 21 d, OB significantly decreased total cholesterol by 12.8% (P less than 0.001), low-density-lipoprotein cholesterol by 12.1% (P less than 0.004), and apolipoprotein B-100 by 13.7% (P less than 0.001) whereas WB had no significant effect. High-density-lipoprotein cholesterol and apolipoprotein A-I did not change significantly in either group. Serum triglycerides decreased by 10% in both groups but the decrease was only significant (P less than 0.04) in WB subjects. OB but not WB significantly reduced total cholesterol and other atherogenic lipoprotein fractions independent of other dietary changes.

Adult↗

PubMed1980

Late results of the Royal Free Hospital prospective controlled trial of prednisolone therapy in hepatitis B surface antigen negative chronic active hepatitis.

A long-term follow-up of at least 10 years or until death of 44 patients taking part in a controlled prospective trial of prednisolone therapy in hepatitis B antigen negative chronic active hepatitis (lupoid hepatitis) has been performed at the Royal Free Hospital, London. Patients presenting between 1963 and 1967 were randomly allocated into control and treatment groups. Ten year life table survival curves showed a significantly improved survival in the treatment group where 63% of patients were alive at 10 years compared with only 27% in the control group (log rank test, P = 0.03). The median survival in the treatment group was 12.2 years compared with 3.3 years in the control group. The mean duration of treatment was 4.5 years. Age, presence of antinuclear factor, cirrhosis, or level of serum transaminases at presentation did not appear to affect survival. Male patients if untreated had a poorer prognosis than females (P = 0.02). The natural history of chronic active hepatitis appeared from clinical, biochemical, and histological findings to be from an active hepatitis or cirrhosis to inactive macronodular cirrhosis. Prednisolone therapy significantly improved survival by reducing mortality in the early active phase of the disease.

Adolescent↗

PubMed1987

A comparison of 3 and 6 weeks' anticoagulation in the treatment of venous thromboembolism.

One hundred hospital in-patients treated for pulmonary embolism (PE) and/or deep vein thrombosis (DVT) were randomly allocated to receive 3 or 6 weeks' anticoagulation with heparin and warfarin. At one year recurrence rates were 12% in the 6 week group and 10% in those treated for 3 weeks. No patient died as a result of recurrence. Our study suggests that 3 weeks' anticoagulation therapy, using intravenous heparin for the first 5 days and warfarin from the third day, is adequate for patients without persisting risk factors.

Adult↗

PubMedDate not supplied

Effect of continuous subcutaneous insulin infusion on kidney function and size in IDDM patients: a 2 year controlled study.

Glomerular filtration rate (GFR), renal plasma flow (RPF), kidney volume, and urinary albumin excretion rate were measured in 24 insulin-dependent diabetics, aged 29 +/- 7 years (mean +/- SD) with diabetes duration of 8 +/- 4 years who were randomly allocated to either continuous subcutaneous insulin infusion (CSII) (n = 12) or unchanged conventional insulin treatment (CIT) (n = 12). GFR, RPF, and kidney volume were identical but significantly increased above normal values in the two groups at the start of the study. After 24 months of CSII treatment, significant reduction in GFR was seen compared to pretreatment values (145 +/- 21 ml/min vs 139 +/- 21 ml/min, 2p less than 5.0%). However, RPF was not reduced after 24 months of CSII treatment (608 +/- 104 ml/min vs 601 +/- 106 ml/min). In the CIT group no changes in GFR or RPF was seen, and kidney volume remained unchanged in both groups; urinary albumin excretion was normal or near normal in both groups and remained unchanged. Thus, improved glycemic control in long-term IDDM patients is associated with normalization (reduction) of renal "hyperfunction," but despite this, no reduction was seen in the associated nephromegaly.

Adult↗